Netflix’s “The Bleeding Edge” Exposes the Horrors the FDA Approves From Medical Device Makers

Continuing their legacy of equally infuriating and enlightening documentaries, the producer-director team of Amy Ziering and Kirby Dick poke into the archaic and futile FDA approval systems for medical devices with their film The Bleeding Edge. Prepare to be scared shitless of vaginal mesh or high-tech surgery robots. Through a series of personal stories from both qualified medical professionals and laypeople, the film explores just what exactly the word complications means on a device’s warnings. In the cases Dick investigates, those complications become a ripple effect of lives ruined by untested but FDA-approved devices.

The film, which premieres on Netflix on July 27, traverses the spectrum of medical devices but opens and closes on one particular item, Essure, a metal coil that’s inserted into the fallopian tubes for sterilization purposes. We meet a mail carrier from upstate New York whose doctor sold her on Essure years ago. As the documentary jumps around to different people, devices and experts, we return again and again to the horrifying story of this mail carrier, who came to find that her body was rejecting the coil, which led her to nearly bleed to death. Another woman, a Latina account executive with four children, relays a frighteningly similar story, only with the added layer of racism; her doctor told her he assumed Latinas just bled more than white women did. Neither woman’s story takes a turn for the better, but it’s the Latina woman whose entire life — and the lives of her daughters — get smashed all because of one doctor not taking her concerns seriously.

Dick seems to anticipate that viewers — just like doctors — may be conditioned to think women overexaggerate their pain, so at the fifteen-minute mark of the film he jumps into the story of a respected older white male doctor who got a cobalt hip joint and began suffering from neurological issues. These were so severe that he had a complete mental breakdown in a hotel room, smashing things and scrawling cryptic messages on the walls. He begins questioning established medicine’s embrace of cobalt implants; upon the removal of his, every neurological issue he had developed disappeared. If a completely healthy man with medical training can go so quickly from zero to delusional, what of the millions of other Americans with cobalt in their bodies? What of the injured vets already fighting PTSD who live with an implant that could be poisoning them? What are the metal plates and screws in my own ankle made of, and why didn’t I know to ask?

The director backs up all these anecdotes with some hard facts about the FDA approval process for medical devices, which — even according to a former head of the department — is a broken system. The medical device industry is the least understood and regulated in the FDA umbrella. Dick exposes so much that I yelled, “Oh, my God!” multiple times while watching. There is nothing more upsetting than listening to a charming Southern woman say the words, “My colon’s falling out!” Worse yet are the profit-hungry companies that have been able to slide by unnoticed for so long. Here’s hoping The Bleeding Edge gets the right attention on a decidedly unsexy topic.

The Bleeding Edge
Directed by Kirby Dick
Opens July 27, IFC Center
Premieres on Netflix on July 27


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Kirby Dick’s The Invisible War Exposes an Epidemic of Rape in the Military

Kirby Dick’s last documentary was titled Outrage, but you could call his newest the same thing. A measured, expertly constructed chronicle of rape in the military, The Invisible War is a humane exposé that does not cease to shock. That includes its own filmmaker.

“After we’d done 40 or so interviews, I would think, ‘I know what the stories are,'” Dick recalls in a phone interview from Los Angeles. “But with each new one, I actually couldn’t believe this happened to a person wanting to serve their country and that this is how the military responded.”

With a discipline matching its milieu, The Invisible War lays bare a disturbing, systemic problem: In the military, rape rates among women number at least one in five, and reporting of the crimes often leads to blame-the-victim retaliation. Dick has assembled a moving litany of testimonials, covering a variety of soldiers and scenarios, giving this heartfelt, steel-nerved, conscientiously argued film an emotional and political maturity rare among “issue” docs. In addition to the voices of the aggrieved (who include men), there are head-clutching interviews with sloganeering military officials. (“Ask her when she’s sober!” runs one cringe-worthy awareness campaign.) Braided throughout are verity tagalongs with one fiery young vet, Kori Cioca, who hacks through VA hotlines while seeking medical coverage for a jaw broken by a superior.

Dick and producer Amy Ziering were inspired by Helen Benedict’s depressing 2007 Salon article on women in Iraq, which they were surprised to discover no one was already adapting.

“It was almost like The Twilight Zone: Not only how could this be, but why aren’t there 100 films being made? Why isn’t everyone reacting to this?” Dick mused, sounding dismayed still now. “Even in the process of raising money, it took a while. I was really shocked.”

The Invisible War, though revelatory, is perhaps the most straightforward film yet from a director who likes to broach the fault lines of sex and society. Dick has repeatedly examined hard-to-face taboos and hypocrisies: abuse by Catholic priests (Twist of Faith, 2004), closeted anti-gay politicians (Outrage, 2009), and the culturally insidious, frequently moronic, and arguably monopolistic MPAA (This Film Is Not Yet Rated, 2006).

Theory-heads could point to his portrait-of-a-deconstructionist Derrida (2002) as one model for Dick’s mode of intelligent questioning. But the fascinating Sick: The Life & Death of Bob Flanagan, Supermasochist (1997) presented his ethos earlier and made a splash in the pre-boom era of documentary with a penis-nailing scene heard round the world.

“It pushes people to consider a perspective that might otherwise have been considered marginal or even not wanted to think about,” says Dick (who, in a neat bit of ’90s outsider-documentary synergy, went to see Crumb with subject Flanagan).

Shockingly, the women and men of The Invisible War qualify as marginalized. Soldier after soldier (one even an investigator herself) report being ostracized, hostage/prey to protocols that sometimes saw assailants adjudicating their victims. One lawsuit on behalf of victims was dismissed on the grounds that rape was an occupational hazard (“incident to service”). Given close-quarter fraternity and a hierarchy undergirded by take-a-bullet trust, military rape is a betrayal that one commentator compares to incest.

That doesn’t mean that Dick has crafted an anti-military screed. On the contrary, The Invisible War rings out with the rank and file reaffirming the boons and lessons they won from the military. Words of dissent are voiced—among them, Cioca’s indelible comment in a military museum that maybe the victims deserve Purple Hearts. But The Invisible War, while unsparing with facts, is never an ideological pile-on.

“Honestly, I think it’s the most positive, pro-military indie film ever made, ironically,” says Ziering, who conducted the (by all accounts) cathartic interviews. Dick aspires to the evenhandedness of responsible reporting, with an emphasis on evidence and anticipating criticism. “In some ways, documentaries have taken over the role that nonfiction books played up until the last decade or so,” he observes. The filmmakers feel this approach is key to reaching the two different audiences they’ve targeted: not only the public but also policy makers.

“The president, the secretary of defense, the [Joint Chiefs of Staff]—those are the people that I want to feel the most pressure, not a half-dozen perpetrators,” Dick says.

In fact, the film, carefully circulated among government muckety-mucks since Sundance, has already achieved the rare documentary distinction of praxis. In April, soon after seeing the film, Secretary of Defense Leon Panetta announced new policies governing rape reporting and prosecution in the armed forces.

It could be a step toward change, though the track record of follow-through isn’t great. Dick is careful to be optimistic but cautious. “I’m somewhat hopeful that this could be a positive thing for society in the long run,” he says. “But they’ve got a long way to go.”

The Invisible War opens June 22 at AMC Loews Village 7. Look for a review in next week’s Voice.